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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K151036
Device Name Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
Applicant
Carefusion 2200, Inc.
72 N. Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact JANE WEBER
Correspondent
Carefusion 2200, Inc.
72 N. Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact JANE WEBER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/20/2015
Decision Date 02/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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